MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD MED ED

Model Number N/A

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the pin from the guide fell off before sterilization cycle.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection confirmed the reported event.Visual checks of the posterior cutting guide are documented in the mar01390.Scratches observed on the main body indicate repeated use of the returned instrument.The fracture surface suggests that the large peg most likely fractured due to bending overload during the surgery.However, it is not possible to identify exactly how this might have occurred from the information provided in the complaint.Device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the pin from the guide fell off before sterilization cycle.

• Brand Name: OXF MP SLOT POST CUT GD MED ED
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7215668
• MDR Text Key: 98413756
• Report Number: 3002806535-2018-00159
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422981
• Device Lot Number: ZB140102
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1